Biopharmaceutical Process Specialist
We are currently recruiting for a dynamic opportunity with a leading organization based in Ireland.
This is an excellent position for anyone who is looking to join a multinational company known for its excellence.
* Develop and maintain qualification/validation documentation and process development studies in line with standard approval processes.
* Contribute to continuous improvement initiatives as appropriate and provide technical input into quality notifications by authorizing/reviewing/approving investigations.
* Execute equipment/qualification validation programs, including re-qualification and re-validation.
* Serve as a technical specialist representative for internal technical group discussions and represent the operations team at global technical forums.
The ideal candidate will have a Bachelor's Degree or higher in a Science, Engineering, or Technical discipline, with a minimum of 3 years' experience in manufacturing, preferably in a GMP setting. Demonstratable experience of leading technical related projects and knowledge of process monitoring systems, automation systems (DeltaV), and operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial.
Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participating in audits and inspections, and proactively highlighting any issues around compliance. Work collaboratively to drive a safe and compliant culture.
Required Skills:
* Process monitoring systems
* Automation systems
* Operational intelligence & data systems
* Leadership skills
* Technical project management
Benefits:
Opportunity to work in a multinational company known for its excellence
Dynamic work environment
Collaborative team
Continuous learning and development opportunities